Method and apparatus for cystocele repair

ABSTRACT

A method for cystocele repair comprising the steps of: establishing four pathways in tissue around a bladder of a patient, introducing a strap into each of said pathways, and positioning beneath said bladder of said patient a support member having each said strap connected thereto such that said bladder of said patient is supported by said support member and a bulge of said bladder into a vagina of said patient is reduced.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/840,646,filed May 7, 2004.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Urogenital Surgery

2. Description of the Related Art

Female genital prolapse has long plagued women. It is estimated by theU.S. National Center for Health Statistics that 247,000 operations forgenital prolapse were performed in 1998. With the increasing age of theU.S. population, these problems will likely assume additionalimportance.

Vaginal prolapse develops when intra-abdominal pressure pushes thevagina outside the body. In a normal situation, the levator ani musclesclose the pelvic floor. This results in little force being applied tothe fasciae and ligaments that support the genital organs. Increases inabdominal pressure, failure of the muscles to keep the pelvic floorclosed, and damage to the ligaments and fasciae all contribute to thedevelopment of prolapse.

Many techniques have been tried to correct or ameliorate the prolapseand its symptoms, with varying degrees of success. Nonsurgical treatmentof prolapse involves measures to improve the factors associated withprolapse, including treating chronic cough, obesity, and constipation.Other nonsurgical treatments may include pelvic muscles exercises orsupplementation with estrogen. These therapies may alleviate symptomsand prevent worsening, but the actual hernia will remain. Vaginalpessaries are the primary type of nonsurgical treatment, but there canbe complications due to vaginal wall ulceration.

There is a desire to obtain a minimally invasive yet highly effectivedevice and method that can be used to treat pelvic organ prolapse withminimal to no side effects. Such a device should reduce the complexityof the surgical procedure, be biocompatible, adjustable, and non-toxic.The treatment methods using the device should reduce pain, operativerisks, infections and post operative hospital stays. Further, the methodof treatment should also improve the quality of life for patients.

SUMMARY OF THE INVENTION

The present invention broadly provides a method and apparatus forcystocele repair. In one embodiment, the method includes the steps of:establishing four pathways in tissue around a bladder of a patient,introducing a strap into each of the pathways, and positioning beneaththe bladder of the patient a support member having each of the strapsconnected thereto such that the bladder of the patient is supported bythe support member. A bulge of the bladder into a vagina of the patientis reduced as a consequence of applying this method.

In another embodiment, an apparatus for repairing cystocele includes asupport surface knitted with a first bar setting and a plurality ofstraps continuously knitted with the support member. The plurality ofstraps are knitted with a second bar setting.

In another embodiment, a kit for repairing cystocele includes a supportapparatus including at least two straps, each of the straps including aconnector configured to mate with a tip of a needle. The kit furtherincludes a first needle configured to extend from an incision on theleft side of the patient where a left inferior edge of the pubic ramusbone of the patient ends at the bottom of the left obturator foramen ofthe patient, through the left obturator foramen of the patient, to anincision in the vagina of the patient; and a second needle configured toextend from an incision on the right side of the patient where a rightinferior edge of the pubic ramus bone of the patient ends at the bottomof the right obturator foramen of the patient, through the rightobturator foramen of the patient, to the incision in the vagina of thepatient.

In another embodiment, a surgical implant kit includes a supportapparatus including at least two straps, each of the straps comprising aconnector configured to mate with a tip of a needle. Each connector hasan aperture configured to receive the tip of the needle. Each aperturehas a different shape. The kit further includes at least two needles,each needle having a tip having a shape configured to mate with oneaperture of the at least two connectors.

In another embodiment, a surgical implant kit includes a supportapparatus including at least two straps, each of the straps including aconnector configured to mate with a tip of a needle. Each connector hasidentifying indicia thereon. The kit further includes at least twoneedles.

In another embodiment, a surgical implant kit includes a supportapparatus including at least two straps, each of the straps including aconnector configured to mate with a tip of a needle. Each connector hasa color. The kit further includes at least two needles, each needlehaving a handle and each handle having a color matching a color of acorresponding connector.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a first embodiment of a supportapparatus of the present invention;

FIG. 2 is a fragmentary front view of a first embodiment of the supportapparatus;

FIG. 3 is a side view of a strap of a support apparatus of the presentinvention;

FIG. 4 is a top view of a front view of a strap of a support apparatusof the present invention;

FIG. 5 is a fragmentary front view of a second embodiment of a supportapparatus of the present invention;

FIG. 6 is a fragmentary front view of a third embodiment of a supportapparatus of the present invention;

FIG. 7 is a front view of a biologic graft attached to a central portionof two straps, each strap having a connector at each end;

FIG. 8 is a front view of a support member including both a biologicgraft and a synthetic support member;

FIG. 8A is a side view of a support member including both a biologicgraft and a synthetic support member;

FIG. 9 is a front view of a support member of the second embodiment ofthe support apparatus;

FIG. 10 is a front view of a support member of the first embodiment ofthe support apparatus;

FIG. 11 is a close up view of the weave pattern of an embodiment of thesupport apparatus;

FIG. 11A is a close up view of an alternate weave pattern for thesupport member;

FIG. 12 is a front view of a surgical kit of an embodiment of thepresent invention;

FIG. 13 is a perspective view of an embodiment of a right superiorneedle (the superior needle held in the surgeon's right hand) of thepresent invention;

FIG. 14 is a top view of an embodiment of the right superior needle ofthe present invention;

FIG. 15 is a bottom view of an embodiment of the right superior needleof the present invention;

FIG. 16 is a left side view of an embodiment of the right superiorneedle of the present invention;

FIG. 17 is a right side view of an embodiment of the right superiorneedle of the present invention;

FIG. 18 is a front view of an embodiment of the right superior needle ofthe present invention;

FIG. 19 is a rear view of an embodiment of the right superior needle ofthe present invention;

FIG. 20 is a side perspective view of an embodiment of a left inferiorneedle shaft of the present invention, without a handle;

FIG. 21 is a front perspective view of an embodiment of the leftinferior needle shaft of the present invention, without a handle;

FIG. 22 is a right side view of an embodiment of a left inferior needleshaft of the present invention, without a handle;

FIG. 23 is a bottom view of an embodiment of the left inferior needleshaft of the present invention, without a handle;

FIG. 24 is a front view of an embodiment of the left inferior needleshaft of the present invention, without a handle;

FIG. 25 is a front view of an embodiment of a left superior strapconnector having symbolic indicia thereon;

FIG. 26 is a front view of an embodiment of a right superior strapconnector having symbolic indicia thereon;

FIG. 27 is a front view of an embodiment of a left inferior strapconnector having symbolic indicia thereon;

FIG. 28 is a front view of an embodiment of a right inferior strapconnector having symbolic indicia thereon;

FIG. 29 is a front view of an embodiment of a set of four needles and asupport apparatus with four connectors, wherein the connectors arematched to the needles using colors;

FIG. 30 is a perspective view of a first needle tip and connector of anembodiment of the present invention;

FIG. 31 is a perspective view of a second needle tip and connector of anembodiment of the present invention;

FIG. 32 is a front view of a patient showing the four needle entryincisions;

FIG. 33 is a perspective view of a right superior needle tip enteringthe left superior incision (the superior incision on the patient's leftside);

FIG. 34 is a perspective view of a right superior needle tip exiting thevaginal incision;

FIG. 35 is a front view of a right superior needle tip exiting thevaginal incision;

FIG. 36 is a perspective view of a right superior needle tip connectedto the right superior connector (the superior connector on the surgeon'sright side);

FIG. 37 is a perspective view of the superior straps and the supportmember in place and the inferior straps extending outside the vaginalincision;

FIG. 38 is a perspective view of a right inferior needle tip exiting thevaginal incision;

FIG. 39 is a perspective view of all the straps and the support memberin place and the sheaths removed;

FIG. 40 is a flow chart illustrating a method of practicing the presentinvention; and

FIG. 41 is a flow chart illustrating an alternate method of practicingthe present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, wherein like reference numerals designateidentical or corresponding parts throughout the several views.

FIGS. 1 and 2 illustrate a surgical support apparatus 10 of a firstembodiment of the present invention. The apparatus 10 is configured tobe surgically implanted in a female patient to repair anterior prolapseof the vagina. The present invention may be used to correct centraldefects, midline defects, or both midline and central defects at once.In the embodiment shown in FIGS. 1 and 2, apparatus 10 comprises twosuperior straps 12, two inferior straps 13, a support member 40, andfour loosening sutures 16. Each of straps 12 and 13 include a connector30. Each strap 12 and 13 is covered by a sheath 14. Each suture 16includes a tab 18. Straps 12 and 13 are connected to tabs 42 and 43 ofsupport member 40 by known means.

In one embodiment, sheath 14 is made of polyethylene. Other material maybe used, such as polypropylene, nylon, polyester, or Teflon. The sheathis configured to be removed from the strap after the strap is in thecorrect position in the body.

In one embodiment, straps 12 and 13 are 19.69 inches long and 0.433inches wide. The straps are 0.024 inches thick. Straps 12 and 13 areknitted of 4 or 6 mil polypropylene monofilament and are heat set at280-300 degrees Fahrenheit for 5-8 minutes. Also, in one embodiment,support member 40 is 10 cm long by 5 cm wide and 0.021 inches thick.Member 40 is knitted of 4 mil polypropylene monofilament and heat set at310-330 degrees Fahrenheit for 5-8 minutes. Both the strap and supportmember have a stitch count of 27.5 courses/inch (±2 courses) and 13wales/inch (±2 wales).

In one embodiment, the straps are knitted with bar settings of: Bar 1:1/0, 2/1 and Bar 2: 0/1, 1/2. The support member is a large pore mesh,knitted with bar settings of: Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0,1/2; Bar 2: 1/0, 2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1,2/3, 2/1. The straps are connected to the support member after knitting.Weaving according to a given bar pattern is described, for example, in“Warp Knitting Production” by Dr. S. Raz, Melliand Textilberichte GmbH,Rohrbacher Str. 76, D-6900 Heidelberg, Germany (1987), the contents ofwhich are incorporated by reference herein.

Straps 12 and 13 and or sheaths 14 may also include indicia thereon tosignify the correct orientation for implantation into a patient. In theembodiment shown in FIGS. 1 and 2, sheaths 14 around straps 12 includeindicia 12A to show that straps 12 are the superior straps, and sheaths14 around straps 13 include indicia 13A to show that straps 13 are theinferior straps. Words, symbols, and colors are all possible indiciathat may be used, and these modifications are intended to be within thespirit and scope of the invention as claimed. Further, the indicia maybe located on the straps, the sheaths, or both.

Apparatus 10 includes dilating connectors 30. Suitable dilatingconnectors are disclosed in Published U.S. Patent Application SerialNos. 2002/151762 and 2002/147382 and U.S. patent application Ser. No.10/386,897, filed Mar. 11, 2003.

Support member 40 is sized and shaped to afford repair of a cystocelewithout lifting the patient's bladder and without placing undue tensionon the bladder or vaginal wall. The shape of member 40 may bepredetermined, or the member may be trimmed based on patient anatomybefore implantation.

FIGS. 3 and 4 illustrate an embodiment of a strap for a surgicalapparatus of the present invention. In one embodiment, strap 12 includestensioning suture 17. Tensioning suture 17 passes through the mesh ofstrap 12 multiple times, as shown in FIGS. 3 and 4. Tensioning suture 17is affixed to strap 12 at points 19, to allow transfer of tension fromthe suture to the strap. In one embodiment, tensioning sutures areincluded in all the straps of the support apparatus. It should bereadily apparent to one skilled in the art that other configurations oftensioning sutures and attachment points to a mesh strap are possible,and these modifications are within the scope of the invention asclaimed.

Tensioning suture 17 is configured to eliminate slack in a strap that isalready surgically implanted in the body. By tightening the strap withsuture 17, rather than pulling on the strap itself, the surgeon preventsdamage to the strap due to deformation. Damage to surrounding tissuesdue to excessive movement of the strap during adjustment is alsoavoided. Straps including tensioning sutures are disclosed in copendingU.S. patent application Ser. No. 10/616,925, incorporated by referenceherein.

Strap 12 also includes a connection point for loosening suture 16. Asdiscussed below, loosening suture 16 is pulled by the surgeon to loosenthe installed support member, if necessary.

FIG. 5 illustrates a second embodiment of the surgical support apparatusof the present invention. Apparatus 110 includes a biological graft fora support member 140. To attach the graft to straps 12 and 13, clamps150 are used to hold the surfaces of the strap and member together. Thesurfaces are then secured together, as discussed below in the method forpreparing the biologic graft. Straps 12 and 13, sheaths 14, andconnectors 30 are described above.

In another embodiment, biologic graft comes in a kit already secured tostraps 12 and 13. In this case, the preparation method below isunnecessary.

FIG. 6 shows a third embodiment of the surgical support apparatus of thepresent invention. Apparatus 210 includes straps 12 and 13, sheaths 14,and support member 240. In this embodiment, support member 240 andstraps 12 and 13 are continuously knitted. Thus, there is no seambetween the straps and support member, as they are one continuous piece.This results in a thinner transition area 243 from the straps to thesupport member, which results in a less bulky apparatus for installmentinto the patient. An apparatus that is less bulky will be less likely toabrade the surrounding tissue.

The support member is knitted with a first bar pattern, and the strapsare knitted with a second bar pattern. This allows larger pores in thesupport member, creating a support member that is more flexible and morelikely to allow tissue ingrowth. A second bar pattern for the strapsallows a smaller pore size for the straps, creating a strap that cancarry a larger load with a smaller, less intrusive strap width.

In one embodiment, the straps and support member are continuouslyknitted of 4 mil polypropylene monofilaments, knitted with a warptricot. The stitch count is 27.5 courses/inch (±2 courses) and 13wales/inch (±2 wales). The support member is a large pore mesh, with barsettings of: Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2: 1/0,2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1. Thethickness of the support member is about 0.21 inches.

FIG. 7 shows an alternate embodiment of the surgical apparatus of thepresent invention. Apparatus 310 includes straps 312 and 313 andbiologic graft 140. Straps 12 and 13 have connectors 30 at each endthereof. Biologic graft 140 is connected to a central portion of eachstrap. In the embodiment shown in FIG. 7, biologic graft 140 isconnected to strap 12 and strap 13 at a portion equidistant from eachend of the straps. It should be readily apparent to one skilled in theart that other configurations are possible, and these modifications arewithin the scope of the invention as claimed.

FIGS. 8 and 8A illustrate a surgical apparatus according to anotheralternate embodiment of the present invention. Apparatus 410 includes abiologic graft 140 and a synthetic support member 40. In the embodimentshown in FIGS. 8 and 8A, biologic graft 140 and synthetic support member40 have the same area and are attached to overlie one another. However,it should be readily apparent to one skilled in the art that a surgicalsupport apparatus having a biologic graft and a synthetic support memberhaving different areas and/or offset from one another could be used, andthese modifications are within the scope of the invention as claimed.Further, apparatus 410 may be implanted in the patient such thatbiologic graft 140 faces the bladder and support member 40 faces thevaginal wall, or such that biologic graft 140 faces the vaginal wall andsupport member 40 faces the bladder. The implantation configuration isbased on the preference of the surgeon.

FIG. 9 shows support member 140 made of a non-synthetic material.Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia, autodermal grafts,dermal collagen grafts, autofascial heterografts, whole skin grafts,porcine dermal collagen, lyophilized aortic homografts, preserved duralhomografts, bovine pericardium and fascia lata. Member 140 includes tabs142 and 143 for connecting to straps, as shown in FIG. 5.

FIG. 10 shows support member 40 made of a synthetic material. Member 40includes tabs 42 and 43 for connecting to straps, as shown in FIG. 1.Commercial examples of synthetic materials include Marlex™(polypropylene) available from Bard of Covington, R. I., Prolene™(polypropylene), Prolene Soft Polypropylene Mesh or Gynemesh(nonabsorbable synthetic surgical mesh), both available from Ethicon, ofNew Jersey, and Mersilene (polyethylene terphthalate) Hernia Mesh alsoavailable from Ethicon, Gore-Tex™ (expanded polytetrafluoroethylene)available from W. L. Gore and Associates, Phoenix, Ariz., and thepolypropylene sling available in the SPARC™ sling system, available fromAmerican Medical Systems, Inc. of Minnetonka, Minn., Dexon™(polyglycolic acid) available from Davis and Geck of Danbury, Conn., andVicry™ available from Ethicon.

Other examples of suitable materials include those disclosed inpublished U.S. patent application Ser. No. 2002/0072694. More specificexamples of synthetic materials include, but are not limited to,polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene,polygalactin, Silastic, carbon-fiber, polyethylene, nylon, polyester(e.g. Dacron) polyanhydrides, polycaprolactone, polyglycolic acid,poly-L-lactic acid, poly-D-L-lactic acid and polyphosphate esters. SeeCervigni et al., The Use of Synthetics in the Treatment of Pelvic OrganProlapse, Current Opinion in Urology (2001), 11: 429-435.

FIGS. 11 and 11A illustrate two possible embodiments for the stitchingof synthetic support member 40. However, it should be readily apparentto one skilled in the art that other knitting patterns are possible, andthese modifications are within the scope of the invention as claimed.

Referring to FIG. 12, in another aspect, the present invention includesa surgical kit 400. The kit 400 preferably includes at least twosuperior needles 70R and 70L. Right superior needle 70R is configured tobe held in the surgeon's right hand and such that the tip of the needleenters an incision on the left side of the patient where the leftadductor longus tendon of the patient inserts into a left portion of thepubic ramus bone of the patient, lateral to the edge of the pubic ramusbone, and travels through the top of the left obturator foramen to exitthrough an incision in the vagina of the patient. Left superior needle70L is configured to be held in the surgeon's left hand and such thatthe tip of the needle enters an incision on the right side of thepatient where the right adductor longus tendon of the patient insertsinto a right portion of the pubic ramus bone of the patient, lateral tothe edge of the pubic ramus bone, and travels through the top of theright obturator foramen to exit through an incision in the vagina of thepatient.

In various embodiments of the present invention, the kits may furtherinclude the needles described in published U.S. patent application Ser.Nos. 20023-0065246-A1; 2002-0151762-A1; 2002-0147382-A1;2002-0107430-A1, U.S. patent application Ser. No. 2002-0099258-A1 andU.S. patent application Ser. No. 2002-0099259-A1; and U.S. ProvisionalApplication Ser. Nos. 60/263,472, filed Jan. 23, 2001; 60/269,829, filedFeb. 20, 2001; 60/281,350, filed Apr. 4, 2001; 60/295,068, filed Jun. 1,2001; 60/306,915, filed Jul. 20, 2001, and 60/332,330, filed Nov. 20,2001. In an embodiment that is particularly suitable for atransobturator surgical procedure, the needles include needles asdescribed in U.S. patent application Ser. No. 10/306,179 filed Nov. 27,2002.

The individual elements of the kits of the present invention may bepackaged together as shown in FIG. 12 with a cover 52 and tray 54.Alternatively, the individual elements may be separately packaged orpackaged in subassemblies depending on a variety of factors such asshelf life and sterilization requirements. They may be assembled at themanufacturing location or at the healthcare location. Any suitablesterilization procedure may be utilized to sterilize the contents of akit. Suitable sterilization techniques include, but are not limited to,steam, ethylene oxide, electron beam, vapor (e.g. hydrogen peroxide orperacetic acid), gamma or plasma procedures.

The kit shown in FIG. 12 includes a support apparatus including a meshsupport member 40. It should be readily apparent to one skilled in theart that kits using biological support members, as described above, maybe made, and these modifications are within the scope of the inventionas claimed. Further, a kit comprising a biologic graft may have thebiologic graft pre-attached to the straps, or the graft may be separatefrom the straps and require the surgeon to attach the straps to thegraft, as discussed below.

The kit shown in FIG. 12 also includes four needles: right inferiorneedle 60R, left inferior needle 60L, right superior needle 70R, andleft superior needle 70L. Embodiments of these needles are shown inFIGS. 13-24 and are described herebelow.

FIGS. 13-19 illustrate an embodiment of right superior needle 70R of thepresent invention. (Left superior needle 70L is a mirror image of theright superior needle 70R.) Right superior needle 70R includes indicia71R, handle 72R, shaft 74R, curved portion 76R, and tip portion 78R.Indicia 71R designates whether the needle is the right or left needle bypointing to the surgeon's right or left side, as the surgeon holds theneedle handle. (The surgeon's right side corresponds to the patient'sleft side.)

FIGS. 20-24 illustrate an exemplary shaft of left inferior needle 60L,without handle 62L. (Right inferior needle 60R is a mirror image of theleft inferior needle 60L.) Left inferior needle 60L includes a handle62L, a shaft 64L, a curved portion 66L, and a tip portion 68L. Leftinferior needle 60L is configured to be held in a surgeon's left handsuch that tip 68L enters an incision 530L on the right side of thepatient where a right inferior edge of the pubic ramus bone of thepatient ends at a bottom of the right obturator foramen of the patient,and travels through the right obturator foramen to exit through anincision in the vagina of the patient. Right inferior needle 60R isconfigured to be held in a surgeon's right hand such that tip 68R entersan incision on the left side of the patient where a left inferior edgeof the pubic ramus bone of the patient ends at a bottom of the leftobturator foramen of the patient, and travels through the left obturatorforamen to exit through an incision in the vagina of the patient. Thisis shown in FIG. 38.

The above-described needles may be disposable or reusable.

FIGS. 25-28 show connectors of the present invention having indiciathereon. FIG. 25 shows left superior connector 330A having indicia 331.Indicia 331 includes symbol 331A indicating that the connector is theleft superior connector. FIG. 26 shows right superior connector 330Bhaving indicia 331. Indicia 331 includes symbol 331B indicating that theconnector is the right superior connector. FIG. 27 shows left inferiorconnector 330C having indicia 331. Indicia 331 includes symbol 331Cindicating that the connector is the left inferior connector. FIG. 28shows right inferior connector 330D having indicia 331. Indicia 331includes symbol 33 ID indicating that the connector is the rightinferior connector. Right connectors are located on the surgeon's rightside and left connectors are located on the surgeon's left side.

FIGS. 25-28 show connectors including symbolic indicia to identify eachconnector. It should be readily apparent to one skilled in the art thatother symbols, markings, or words could be used to identify theconnectors, and that these modifications are within the scope of theinvention as claimed.

FIG. 29 shows another embodiment of the present invention whereinconnectors and the handles of the corresponding needles are matchingcolors. For example, the color of the handle of needle 70L matches thecolor of connector 430A. The color of the handle of needle 70R matchesthe color of connector 430B. The color of the handle of needle 60Rmatches the color of connector 430D. The color of the handle of needle60L matches the color of connector 430C.

FIGS. 30 and 31 are perspective views of a needle tips having a crosssections that are configured to match the cross sections of a connectoraperture. FIG. 30 shows that the cross section of portion 450A of needletip portion 478A is a triangle. The cross section of portion 450Amatches triangle shaped aperture 460A in connector 490A. FIG. 31 showsthat the cross section of portion 450B of needle tip portion 478B is asquare. The cross section of portion 450B matches square shaped aperture460B in connector 490B.

In one embodiment, each needle tip has a cross section that matches thecross section of an aperture of the corresponding connector, and the tipcross section is incompatible with the other connector apertures. Forexample, the cross section of the portion 450A, a triangle, would notfit in aperture 460B, a square, and vice versa. Thus, even if theconnectors are confused, it is physically impossible for a surgeon toinsert the needle tip in the incorrect connector without damaging thetip or connector. It should be readily apparent to one skilled in theart that other shaped tips and apertures are possible, and thesemodifications are within the scope of the invention as claimed.

Example of a Surgical Procedure

The following description, illustrated in FIGS. 32-39, is an exemplarymethod for using the disclosed surgical support apparatus 10 having amesh support member 40. It should be readily apparent to those skilledin the art that modifications may be made to the following method, andthese modifications are within the scope of the invention as claimed.

If the embodiment of the surgical support apparatus 110 including abiological support member 140 is used, the biological support member 140must be prepared before making the vaginal incision. Instructions forpreparing the biological support member are given after the presentdescription.

In preparation for surgery, the patient is placed in a modified dorsallithotomic position with hips flexed, legs elevated in stirrups andbuttocks even with edge of the surgical table. The patient's bladder isemptied. A catheter is not required during the procedure, but may aid inidentifying the urethra during the procedure. A weighted vaginalretractor or other suitable vaginal retraction is used, if desired.

The length of the vaginal incision is marked with a skin pencil startingbelow the bladder neck, over the most prominent part of the prolapse, tothe lowermost part of the prolapse. (Variations may occur in specificincisions due to individual technique and patient anatomy.) An incisionis made over this marking. The incision site may be infiltrated withsaline, if desired. An Allis forceps is placed on the incision margin toexpose the incision. The patient's bladder is dissected off the vaginaup to the lateral sulcus and posterior to the vaginal vault. Thisdissection allows palpation of the medial edge of the inferior pubicramus, assisting in guiding the superior and inferior needles to theexit points free from the bladder. The patient's cystocele is thenreduced using midline plication, if desired.

Next, markings are made to identify the locations for needle entryincisions. The vaginal dissection is completed prior to marking needleentry incisions to allow for digital palpation along the ischiopubicramus. The needle entry points are palpated internally and externallywith the thumb and index finger before marking, as discussed hereafter.

The edge of the ischiopubic ramus beginning at the level of the vaginalincision is palpated, continuing along the edge of the bone cephaladtoward the level of the clitoris denoting where the adductor longustendon inserts into the pubic ramus. The superior skin incisions aremarked approximately at this location and lateral to the edge of thebone. The markings are made according to the same method on both sides(right and left) of the patient's body. Both marks lie in a straightline at the approximate level of the clitoris. The edge of the inferiorpubic ramus is palpated until it ends at the bottom of the obturatorforamen. The inferior skin incisions are then marked. The inferior skinincisions are located at a point approximately 3 centimeters below and 2centimeters lateral to the superior marks. Again, the markings are madeaccording to the same method on both sides of the patient's body.

A small vertical stab incision is made over all four markings to provideneedle entry incisions. Right superior incision 540R, left superiorincision 540L, right inferior incision 530R, and left inferior incision530L are all shown in FIG. 32. (Right and left with regard to theincisions are the patient's right and left sides.)

The above-described surgical kit is opened. The package integrity ischecked to ensure that the kit was not compromised in shipping, and thecomponents of the kit are inspected for damage.

The following method describes the straps on the surgeon's right side(the patient's left side) being surgically installed before the strapson the surgeon's left side (the patient's right side). However, itshould be readily apparent to one skilled in the art that the straps ofeither side could be installed first, and this modification is withinthe scope of the invention as claimed.

Tip 78R of right superior needle 70R is now inserted through leftsuperior incision 540L, through the left obturator foramen, and thenthrough the vaginal incision 524. Tip of right superior needle 70R ispointed perpendicular to the skin with tip 78R in the left superiorincision 540L, shown in FIG. 33. The thumb from the surgeon's right handis on the outside curve of needle to control the needle movement as itperforates the obturator membrane and muscle. The right thumb pushes theneedle through the obturator muscle and membrane. The needle shaft andhandle is positioned at a 45° angle to the patient's vertical axis andclose to the patient's body. The needle handle is rotated to move theneedle tip and curve around the posterior surface of the ischial pubicramus toward the vaginal incision and index finger. (If the needle tiphits the pubic bone during rotation, the needle is retracted. The needletip is then penetrated beyond initial insertion depth and rotate againtoward the vaginal incision.) The needle tip is palpated with thesurgeon's finger. The finger meets the needle tip as it moves around thepubic ramus. (If the needle tip can not be located, the needle tip isretracted to just behind the pubic ramus and advanced again.) The needletip is guided by the surgeon with the surgeon's finger towards thevaginal incision until the needle tip extends through the vaginalincision, shown in FIGS. 34 and 35.

The support member is then oriented so that the tail of the graft ispointing away from the surgeon. (The marking indicia disclosed hereinmay be used to determine the correct orientation of the support member.)The right superior connector is connected to the tip of the rightsuperior needle, the tip extending out of the vaginal incision, as shownin FIG. 36. The superior needle connectors are closest to the leadingedge of the graft that will be below the bladder neck.

Before attaching the connectors, the surgeon ensures that theself-fixating mesh and graft are not twisted, as the connectors are notremovable once snapped onto the needle. Once the connector is attachedto the needle, the needle is rotated back through the skin incisionpulling the connector and associated plastic insertion sheath and graftinto position.

The above process is repeated with the left needle on the patient'sright side. The partially implanted apparatus is shown in FIG. 37, withsuperior straps and support member 40 implanted and the inferior strapsextending outside the body through the vaginal incision.

The insertion sheaths and mesh are then cut below the blue mark on theend portion of the plastic sheath and discarded. This step allows thesheath to slide freely relative to the mesh. The sheaths are not removedat this time.

The tip of the right inferior needle is now inserted through leftinferior incision 530L, through the left obturator foramen, and thenthrough the vaginal incision. The tip of the right inferior needle ispointed perpendicular to the skin with the tip in the left inferiorincision. The exit point for the needle is confirmed to be clear of thebladder wall by the surgeon placing their right index finger at thedistal end of the vaginal incision and visualizing where needle exitsthe distal end of vaginal incision. The surgeon's right thumb is on theoutside curve of needle to control the needle movement as it perforatesthe obturator membrane and muscle. The right thumb pushes the needlethrough the obturator muscle and membrane.

The needle shaft and handle is positioned parallel to the patient'svertical axis and close to the patient's body. The needle handle isrotated, moving the needle tip and curve toward the distal end of thevaginal incision. The surgeon is careful to avoid buttonholing thefornix to prevent bleeding. The needle tip is palpated as it movesthrough the distal end of the vaginal incision. The right inferiorneedle tip is shown extending outside the vaginal incision in FIG. 38.

The right inferior connector is connected to the right inferior needletip. Again, before attaching the connectors, the surgeon ensures thatthe self-fixating mesh and graft are not twisted, as the connectors arenot removable once snapped onto the needle. The needle is rotated backthrough the skin incision pulling the connector and associated plasticinsertion sheath and graft into position.

The above process is repeated with the left inferior needle on thepatient's right side.

The insertion sheath and mesh are then cut below the blue mark on theend portion of the plastic sheath and discarded. This step allows thesheath to slide freely relative to the mesh. The sheaths are not removedat this time.

A cystoscopy is done to check the integrity of the ureters and bladder.

Any vaginal retraction is now removed to allow adjusting the tension ofthe mesh to reduce bladder bulge. The surgeon confirms the mesh is lyingflat and not overlapping under the vaginal wall. The superior leadingedge of the support member should be positioned below the bladder neckwithout tension. The inferior tail portion of the support member shouldbe positioned at the distal end of the vaginal incision or towards thevaginal apex without tension.

If the mesh needs to be loosened, an instrument is placed between themesh and vaginal wall and pulled down, or away from the vaginal walluntil proper tension is achieved.

Each of the four plastic sheaths are removed and discarded, whileensuring the support member graft is not being over tensioned. Once theplastic sheaths are removed, further adjustment is minimized.

If the mesh needs to be tightened, the tensioning suture exiting theskin incision on each side is grasped using a hemostat. The suture iswrapped around the hemostat to improve the grip and pulled up or out totighten until proper tension is achieved.

To loosen a biologic graft, the surgeon uses a hemostat or a clamp topull from each of the hanging loosening sutures. The surgeon uses theclamps to pull down and loosen the strap mesh as desired. The surgeon iscareful not to pull on tab 18 on loosening suture 16 to loosen the strapmesh.

The surgeon cuts one end of each loosening sutures and pulls tab 18until the entire loosening suture is removed. The mesh is then trimmedat the level of the subcutaneous tissue and all five incisions areclosed. Excess vaginal tissue may be excised. Variations of this stepmay occur due to individual technique and patient anatomy. The finalimplanted apparatus is shown in FIG. 39.

After the operation, a catheter and/or vaginal pack can be used at thediscretion of the surgeon. It is removed prior to discharge. Antibioticprophylaxis should be given. The ability of the patient to empty thebladder should be confirmed prior to discharge.

If a biologic graft is used, the following steps are performed beforemaking the vaginal incision. The biologic graft is removed from thepackage and prepared per included instructions, if needed. A precutbiologic is prepared by orienting the graft with the tail portionpointing at the surgeon. Beginning with the right or left inferiorlanding tabs on the biologic graft (closest to the surgeon), the graftis attached to clamps 150. Attaching the inferior tabs first allowsspace to attach the two superior mesh appendages with the clamp. Theclamps are squeezed to separate mesh tape. The graft material isinserted into the open clamp using printed marks as guides to center thegraft. (The printed side of the plastic sheath is facing the surgeon asthe surgical apparatus is placed in the body.) The clamp is released tosecure graft material. A desired suture is passed up through the clampusing a suturing mark as a guide. The suture is then passed down usingthe opposite suturing mark as the guide. The passed sutures are thensecured using the surgeon's knot(s) of choice. Additional throws aremade if needed. The clamp sutures are cut by passing a scissors or ascalpel down the scissors slot on each side of the clamp. The clamps arethen removed. The clamp attachment sutures remain with the clamp. Thesurgeon assesses the attachment of the graft material mesh tape. Theprotective sheath is slid over the mesh connection to aid deployment.

The preceding steps are repeated on the opposite side of the graft. Thesutures are passed such that the attachment knots are all on the sameside of the graft. The biologic is placed in a saline bath to keep ithydrated during the remainder of the procedure. The graft tail istrimmed at the time of vaginal marking and dissection to reflectpatients anatomy, if needed.

In addition, when using the biologic graft, the surgeon is careful whendrawing the strap through the body that the sheath covers the graftconnections and that the graft material and graft connections are notdamaged.

FIG. 40 illustrates one embodiment of method of practicing the presentinvention. Method 600 includes the steps of: establishing four pathwaysin tissue around a bladder of a patient (step 610), introducing a strapinto each of the pathways (step 620), and positioning beneath thebladder of the patient a support member having each strap connectedthereto such that the bladder of the patient is supported by the supportmember and a bulge of the bladder into the vagina of the patient isreduced (step 630). Step 610 comprises the steps of: making an incisionin the vagina of the patient (step 612), making an incision on a leftside of the patient where a left adductor longus tendon of the patientinserts into a left portion of the pubic ramus bone of the patient,lateral to an edge of the pubic ramus bone (step 614), making anincision on a right side of the patient where a right adductor longustendon of the patient inserts into a right portion of the pubic ramusbone of the patient, lateral to an edge of the pubic ramus bone (step616), making an incision on a left side of the patient where a leftinferior edge of the pubic ramus bone of the patient ends at the bottomof the left obturator foramen of the patient (step 618), and making anincision on a right side of the patient where a right inferior edge ofthe pubic ramus bone of the patient ends at the bottom of the rightobturator foramen of the patient (step 619).

FIG. 41 illustrates an alternate embodiment of method of practicing thepresent invention. Method 700 includes the steps of: establishing fourpathways in tissue around a bladder of a patient (step 710),atraumatically dilating the pathways (step 720), introducing a strapinto each of the pathways while the pathways are atraumatically dilated(step 730), and positioning beneath the bladder of the patient a supportmember having each strap connected thereto such that the bladder of thepatient is supported by the support member and a bulge of the bladderinto the vagina of the patient is reduced (step 740). Step 710 comprisesthe steps of: making an incision in the vagina of the patient (step712), making an incision on a left side of the patient where a leftadductor longus tendon of the patient inserts into a left portion of thepubic ramus bone of the patient, lateral to an edge of the pubic ramusbone (step 714), making an incision on a right side of the patient wherea right adductor longus tendon of the patient inserts into a rightportion of the pubic ramus bone of the patient, lateral to the edge ofthe pubic ramus bone (step 716), making an incision on a left side ofthe patient where a left inferior edge of the pubic ramus bone of thepatient ends at the bottom of the left obturator foramen of the patient(step 718), and making an incision on a right side of the patient wherea right inferior edge of the pubic ramus bone of the patient ends at thebottom of the right obturator foramen of the patient (step 719).

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the above teachings. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced otherwise than as specifically describedherein.

1. A surgical repair kit comprising: a support apparatus comprising atleast two straps, each of said straps comprising a connector configuredto mate with a tip of a needle; a first needle configured to extend froman incision on a right side of a patient where a right adductor longustendon of said patient inserts into a right portion of a pubic ramusbone of said patient, lateral to an edge of said pubic ramus bone,through a right obturator foramen of said patient, to an incision in avagina of said patient; and a second needle configured to extend from anincision on a left side of said patient where a left adductor longustendon of said patient inserts into a left portion of said pubic ramusbone of said patient, lateral to an edge of said pubic ramus bone,through a left obturator foramen of said patient, to said incision insaid vagina of said patient, wherein said support apparatus comprises: asubstantially rectangular member having two short sides and two longsides, a first end of said rectangular member at a first of said twoshort sides, a second end of said rectangular member at a second of saidtwo short sides; a first strap connected to a first long side proximatesaid first end of said member; a second strap connected to a second longside proximate said first end of said member; a third strap connected tosaid first long side proximate a middle portion of said first long sideand spaced from said second end; and a fourth strap connected to saidsecond long side proximate a middle portion of said second long side andspaced from said second end.
 2. The kit recited in claim 1 wherein saidsupport apparatus comprises a biologic graft.
 3. The kit recited inclaim 2 wherein said biologic graft is pre-attached to said at least twostraps.
 4. The kit recited in claim 1 wherein said support apparatuscomprises: a pair of straps, each strap having a central portion and aconnector at each end of said strap; and a biologic graft connected tosaid central portion of each strap.
 5. The kit recited in claim 1wherein said support apparatus comprises a biologic graft fixed over aknitted support member.
 6. The kit recited in claim 1 wherein saidsupport apparatus comprises: a support member knitted with a first barsetting; and a plurality of straps continuously knitted with saidsupport member, said plurality of straps knitted with a second barsetting.
 7. The apparatus recited in claim 6 wherein said first barsetting is: Bar 1: 1/0, 2/3, 2/1, 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2: 1/0,2/3, 2/3, 1/0; and Bar 3: 2/3, 1/0, 1/2, 1/0, 2/3, 2/1, 2/3, 2/1.
 8. Thekit recited in claim 1 further comprising: a third needle configured toextend from an incision on said right side of said patient where a rightinferior edge of said pubic ramus bone of said patient ends at a bottomof said right obturator foramen of said patient, through said rightobturator foramen of said patient, to said incision in said vagina ofsaid patient; and a fourth needle configured to extend from an incisionon said left side of said patient where a left inferior edge of saidpubic ramus bone of said patient ends at a bottom of said left obturatorforamen of said patient, through said left obturator foramen of saidpatient, to said incision in said vagina of said patient.
 9. A kitaccording to claim 1 wherein: each strap comprises a plastic sheath,each needle comprises a helical portion, each connecter is configured tomate with a needle tip to produce a substantially permanent attachmentbetween the connector and the needle tip.
 10. A kit according to claim 1wherein each needle comprises a handle and each handle comprises alength, a longitudinal axis along the length, opposing major surfacesalong the length, opposing minor sides, and a cross section of eachhandle along the longitudinal axis exhibits an elongate, non-circularform.
 11. A kit according to claim 9 wherein each needle comprises ahandle and each handle comprises a length, a longitudinal axis along thelength, opposing major surfaces along the length, opposing minor sides,and a cross section of each handle along the longitudinal axis exhibitsan elongate, non-circular form.
 12. A kit according to claim 1 whereinat least one needle has a proximal end and a handle permanently attachedto the proximal end.
 13. A kit according to claim 9 wherein at least oneneedle has a proximal end and a handle permanently attached to theproximal end.
 14. A kit according to claim 1 wherein each strapcomprises a tensioning suture.
 15. A kit according to claim 9 whereineach strap comprises a tensioning suture.
 16. A kit according to claim 1wherein a connector includes an aperture configured to mate with aneedle tip, the aperture having a shape that corresponds to a shape ofthe needle tip, the shape allowing entry of the needle tip into theconnector at at least one rotational orientation of the needle tiprelative to the connector, while preventing entry of the needle tip intothe connector at at least one other rotational orientation of the needletip relative to the connector.
 17. A kit according to claim 16 whereinthe shape is selected from a shape having a triangle cross section and ashape having a square cross-section.
 18. A kit according to claim 9wherein a connector includes an aperture configured to mate with aneedle tip, the aperture having a shape that corresponds to a shape ofthe needle tip, the shape allowing entry of the needle tip into theconnector at at least one rotational orientation of the needle tiprelative to the connector, while preventing entry of the needle tip intothe connector at at least one other rotational orientation of the needletip relative to the connector.
 19. A kit according to claim 18 whereinthe shape is selected from a shape having a triangle cross section and ashape having a square cross-section.
 20. A kit according to claim 9wherein each needle comprises a handle and each handle comprises alength, a longitudinal axis along the length, opposing major surfacesalong the length, opposing minor sides, and a cross section of eachhandle along the longitudinal axis exhibits an elongate, non-circularform; at least one needle has a proximal end and a handle permanentlyattached to the proximal end, each strap comprises a tensioning suture;and a connector includes an aperture configured to mate with a needletip, the aperture having a shape that corresponds to a shape of theneedle tip, the shape allowing entry of the needle tip into theconnector at at least one rotational orientation of the needle tiprelative to the connector, while preventing entry of the needle tip intothe connector at at least one other rotational orientation of the needletip relative to the connector.
 21. A surgical implant kit comprising: asupport apparatus comprising at least two straps, each of said strapscomprising a connector configured to mate with a tip of a needle, eachconnector having an aperture configured to receive said tip of saidneedle, wherein at least one connector includes an aperture configuredto receive a tip of a needle, the aperture having a shape thatcorresponds to a shape of the needle tip, the shape allowing entry ofthe needle tip into the connector at at least one rotational orientationof the needle tip relative to the connector, while preventing entry ofthe needle tip into the connector at at least one other rotationalorientation of the needle tip relative to the connector.
 22. A kitaccording to claim 1 wherein said first strap extends parallel to saidthird strap and said second strap extends parallel to said fourth strap.23. A kit according to claim 1 wherein said third strap and said fourthstrap are parallel to the first end.
 24. A kit according to claim 1wherein said rectangular member has a length taken in the direction ofthe two long sides and a width taken in the direction of the two shortsides, and wherein the length is greater than the width.
 25. A kitaccording to claim 24 wherein each of said first strap, second strap,third strap, and fourth strap extends from said rectangular member indirections parallel to a two short side.
 26. A kit according to claim 1wherein the two short sides are parallel to one another, and least aportion of one of the two long sides is parallel to at least a portionof the other of the two long sides.